Trifluridine NDC 61314-044

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0044Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
61314-044-75	61314004475	1 BOTTLE, PLASTIC in 1 CARTON (61314-044-75) / 7.5 mL in 1 BOTTLE, PLASTICMarketed from May 14, 2001

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Trifluridine
Generic name (nonproprietary): trifluridine
Active ingredients: Trifluridine — 10 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074311
Marketing start: May 14, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 61314-044_d0e32882-06fe-4062-adae-3751ffc9979fSPL ID d0e32882-06fe-4062-adae-3751ffc9979fSPL set ID abc1d07f-91ee-4421-bc9b-457d0ed41f4cRxCUI 313477UNII RMW9V5RW38
Pharmacologic class: Nucleoside Analog Antiviral; Nucleoside Metabolic Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N461314004475 followed by a unit qualifier and the quantity

Package 61314-0044-75. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 1, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)